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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06161571




Registration number
NCT06161571
Ethics application status
Date submitted
22/11/2023
Date registered
8/12/2023

Titles & IDs
Public title
A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Secondary ID [1] 0 0
AK-US-001-0107
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NASH/MASH 0 0
NAFLD/MASLD 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Liver
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Efruxifermin
Treatment: Drugs - Placebo

Experimental: EFX 50 mg -

Placebo comparator: Placebo -

Experimental: EFX 50 mg (Open-Label Rollover) -


Treatment: Drugs: Efruxifermin
Administered by subcutaneous (SC) injection

Treatment: Drugs: Placebo
Administered by SC injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Extent of exposure
Timepoint [1] 0 0
52 Weeks
Primary outcome [2] 0 0
Number of participants with adverse events
Timepoint [2] 0 0
52 Weeks
Primary outcome [3] 0 0
Number of participants with adverse events by severity
Timepoint [3] 0 0
52 Weeks
Primary outcome [4] 0 0
Number of participants with clinically significant changes in clinical assessments
Timepoint [4] 0 0
52 Weeks
Secondary outcome [1] 0 0
Change from baseline in non-invasive marker fibroscan® aspartate aminotransferase (FAST) score
Timepoint [1] 0 0
52 Weeks
Secondary outcome [2] 0 0
Change from baseline in non-invasive marker enhanced liver fibrosis (ELF) score
Timepoint [2] 0 0
52 Weeks
Secondary outcome [3] 0 0
Change from baseline in non-invasive marker pro-peptide of type 3 procollagen (Pro-C3)
Timepoint [3] 0 0
52 Weeks
Secondary outcome [4] 0 0
Change from baseline in non-invasive marker liver stiffness assessed by transient elastography (kPa, CAP)
Timepoint [4] 0 0
52 Weeks
Secondary outcome [5] 0 0
Change from baseline in lipoproteins
Timepoint [5] 0 0
52 Weeks
Secondary outcome [6] 0 0
Change from baseline in markers of glycemic control: HbA1c (%)
Timepoint [6] 0 0
52 Weeks
Secondary outcome [7] 0 0
Change from baseline in markers of glycemic control: adiponectin (mg/L)
Timepoint [7] 0 0
52 Weeks
Secondary outcome [8] 0 0
Change from baseline in markers of liver injury
Timepoint [8] 0 0
52 Weeks
Secondary outcome [9] 0 0
Change from baseline in markers of liver injury: uric acid (mg/dL)
Timepoint [9] 0 0
52 Weeks
Secondary outcome [10] 0 0
Change from baseline in body weight (kg)
Timepoint [10] 0 0
52 Weeks

Eligibility
Key inclusion criteria
Main Study Only:

* Males and non-pregnant, non-lactating females between 18 - 80 (between 19-80 in the Republic of Korea) years of age inclusive, on the day of signing informed consent
* Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes
* Suspected or confirmed diagnosis of NASH/MASH or NAFLD/MASLD or non-invasively diagnosed NASH/MASH or NAFLD/MASLD

Open-Label Rollover

* Prior participation in the placebo arm of a previous Akero Phase 2 study
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results, including but not limited to: alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis [PBC], primary sclerosing cholangitis [PSC], autoimmune hepatitis), drug induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency
* Type 1 or unstable Type 2 diabetes

A reduced list of inclusion and exclusion criteria apply to participants in the open-label rollover extension.

Other inclusion and exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2026
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Akero Clinical Study Site - Broadmeadow
Recruitment hospital [2] 0 0
Akero Clinical Study Site - Westmead
Recruitment hospital [3] 0 0
Akero Clinical Study Site - Adelaide
Recruitment hospital [4] 0 0
Akero Clinical Study Site - Clayton
Recruitment hospital [5] 0 0
Akero Clinical Study Site - Epping
Recruitment hospital [6] 0 0
Akero Clinical Study Site - Heidelberg
Recruitment hospital [7] 0 0
Akero Clinical Study Site - Melbourne
Recruitment hospital [8] 0 0
Akero Clinical Study Site - Murdoch
Recruitment hospital [9] 0 0
Akero Clinical Study Site - Perth
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3076 - Epping
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment postcode(s) [9] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New Mexico
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
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United States of America
State/province [26] 0 0
Utah
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Washington
Country [29] 0 0
Argentina
State/province [29] 0 0
Buenos Aires
Country [30] 0 0
Argentina
State/province [30] 0 0
Distrito Federal
Country [31] 0 0
Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
India
State/province [33] 0 0
Delhi
Country [34] 0 0
India
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Gujarat
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India
State/province [35] 0 0
Kerala
Country [36] 0 0
India
State/province [36] 0 0
Maharashtra
Country [37] 0 0
India
State/province [37] 0 0
Punjab
Country [38] 0 0
India
State/province [38] 0 0
Rajasthan
Country [39] 0 0
India
State/province [39] 0 0
Tamil Nadu
Country [40] 0 0
India
State/province [40] 0 0
Telangana
Country [41] 0 0
India
State/province [41] 0 0
Uttar Pradesh
Country [42] 0 0
India
State/province [42] 0 0
West Bengal
Country [43] 0 0
Israel
State/province [43] 0 0
Central District
Country [44] 0 0
Israel
State/province [44] 0 0
Haifa District
Country [45] 0 0
Israel
State/province [45] 0 0
Northern District
Country [46] 0 0
Israel
State/province [46] 0 0
Jerusalem
Country [47] 0 0
Israel
State/province [47] 0 0
Tel Aviv
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Daegu Gwang'yeogsi
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Gyeonggi-Do
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Gyeonggi-do
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Gyeongsangbugdo
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Seoul Teugbyeolsi
Country [54] 0 0
Puerto Rico
State/province [54] 0 0
Manatí
Country [55] 0 0
Puerto Rico
State/province [55] 0 0
San Juan
Country [56] 0 0
Switzerland
State/province [56] 0 0
Solothurn
Country [57] 0 0
Switzerland
State/province [57] 0 0
Bern
Country [58] 0 0
Switzerland
State/province [58] 0 0
Sankt Gallen
Country [59] 0 0
Taiwan
State/province [59] 0 0
Changhua
Country [60] 0 0
Taiwan
State/province [60] 0 0
Taichung
Country [61] 0 0
Taiwan
State/province [61] 0 0
Tainan
Country [62] 0 0
Taiwan
State/province [62] 0 0
Taipei City
Country [63] 0 0
Turkey
State/province [63] 0 0
Ankara
Country [64] 0 0
Turkey
State/province [64] 0 0
Izmir
Country [65] 0 0
Turkey
State/province [65] 0 0
Bursa
Country [66] 0 0
Turkey
State/province [66] 0 0
Rize
Country [67] 0 0
United Kingdom
State/province [67] 0 0
England

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Akero Therapeutics, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Akero Study Director
Address 0 0
Country 0 0
Phone 0 0
650-487-6488
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06161571